Clinical trial · Interventional
Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer
Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
NCT00891332CI-TRIAL-00006070completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1 plus LV (The combination therapy of S-1 and Leucovorin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- S-1 plus LV
- interventionNames
- Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- During chemotherapy
Secondary outcomes (7)
- measure
- Safety
- timeFrame
- During chemotherapy
- measure
- Progression free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proved adenocarcinoma * Unresectable and recurrent colorectal cancer * Age20 ≤ at enrollment * Performance status 0 or 1 (ECOG) * No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded * Adequate hematologic, hepatic and renal functions * At least one measurable lesion by RECIST criteria Exclusion Criteria: * Serious drug hypersensitivity * Pregnant or nursing * Bleeding from gastrointestinal tract * Diarrhea * Simultaneously active double cancer * Serious illness or medical condition * Brain metastasis
References
Publications (0)
Data not yet available
No reference posted for this study.